High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis

NCT ID: NCT01603199

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-06-30

Brief Summary

Primary biliary cirrhosis is a chronic cholestatic autoimmune liver disease with a progressive course that can lead to liver cirrhosis. There are few studies on dietary management in primary biliary cirrhosis and most of them have focused on micronutrients specifically vitamin D intake to prevent osteoporosis, and lipid control to prevent hyperlipidemia, but few recommendations have been made regarding a complete dietary approach. Fiber has been proven to increase the excretion of nitrogen products and consequently reduce its blood levels, and an adequate protein intake (1- 1.5 g per kg) has shown to decrease endogenous catabolism in cirrhotic patients.

The purpose of this study is to evaluate the impact of a high-protein, high-fiber diet in the nutritional status of patients with primary biliary cirrhosis.

Conditions

Primary Biliary Cirrhosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Primary biliary cirrhosis (Non-cirrhotic)

Group Type: EXPERIMENTAL

High protein high fiber diet

Intervention Type: DIETARY_SUPPLEMENT

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.

Primary biliary cirrhosis (Cirrhotic)

Group Type: EXPERIMENTAL

High protein high fiber diet

Intervention Type: DIETARY_SUPPLEMENT

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.

Interventions

High protein high fiber diet

A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Controls

Diagnose of primary biliary cirrhosis:

• Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
• Presence of antimitochondrial antibodies (AMA)
• Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Ambulatory patients

• Cases

Diagnose of primary biliary cirrhosis:

• Biochemical evidence of cholestasis: based mainly on alkaline phosphatase elevation
• Presence of antimitochondrial antibodies (AMA)
• Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts.

Diagnose of liver cirrhosis by two or more of the following criteria:

• Albumin < 3.4 g/dL
• INR ≥ 1.3
• Total bilirubin ≥ 2 mg/dL
• Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)
• Liver biopsy Ambulatory patients

Exclusion Criteria

• Overlapping syndrome with predominant autoimmune hepatitis
• Hospitalized patients
• Acute or chronic renal failure
• Hepatocellular carcinoma
• Pregnancy
• Neuropsychiatric disorders (Schizophrenia, bipolar disorder, dementia and attention-deficit hyperactivity disorder)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

ALDO TORRE DELGADILLO

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo Torre Delgadillo, M.D. M.Sc

Role: STUDY_CHAIR

INCMNSZ

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

GAS-460-11/12-1

Identifier Type: -

Identifier Source: org_study_id